Companion diagnostics (CDx)
The Alcimed team has been supporting healthcare players for more than 15 years to seize opportunities around companion diagnostics (CDx). We help our clients, whether industrial leaders, start-ups or healthcare establishments, to assess the potential of these new technologies, to build their development roadmaps or to integrate CDx into care pathways.
Challenges related to companion diagnostics (CDx)
What are companion diagnostics or CDx?
Unlike a conventional diagnostic test that aims to determine the pathology from which a patient suffers, a companion diagnostic test is carried out on a patient whose pathology is known. Its purpose is to determine the patient’s precise profile in order to adapt the therapeutic decision according to the patient. As such, companion diagnostics (CDx) are a perfect example of targeted and personalized medicine, and expand the range of tools available to precision medicine.
A companion diagnostic test is specific to a treatment, hence the term “companion”. It was the Roche laboratory that was the first to open up this path at the end of the 1990s with the marketing of Herceptin, a breast cancer treatment associated with HercepTest, the companion test to identify women suffering from tumor overexpressing the HER2 receptor, and therefore likely to respond favorably to treatment.
Since then, the use cases of companion diagnostics have developed, and today there are several possible uses:
- Identifying patients likely to respond to treatment
- Identifying patients at risk of developing adverse effects to a given treatment
- Predicting and tracking response to treatment
Most companion diagnostics are molecular tests, i.e. they are based on the detection of a specific biomarker. Thus, the triage of patients is done through the analysis of a predictive biomarker targeted by the test using molecular biology techniques.
What are the challenges related to companion diagnostics and molecular diagnostic tests?
Companion diagnostics have made it possible to make a leap in the efficiency of care, by helping to better target the patients to whom a particular treatment should be prescribed. In addition, for treatments where each dose is sometimes worth several thousand euros, having such an upstream patient identification tool is a real opportunity to avoid waste beyond the side effects for patients who can’t benefit from the treatment.
For these reasons, the CDx market is booming, but pharmaceutical companies are faced with many challenges:
How do we guide the search for a biomarker for a given treatment? What level of sensitivity/specificity should we aim for?
What balance should be struck between innovation, cost, ease of use and access? What is the level of knowledge and adoption of these technologies by healthcare professionals?
Which business model should we adopt for a CDx? What regulatory process sequence should be followed to optimize companion diagnostic test launches?
How do we evaluate the market potential of a CDx and the competitive advantage it provides? Which product in the portfolio is the most relevant to develop a companion diagnostic? How can we evaluate the return on investment of these innovations for the pharmaceutical company and for the company that will develop the test?
In a market where several major players such as Roche Diagnostics, Qiagen or Abbott Diagnostics compete, how do we identify the right partner? Who are the new players? How is the value distributed between partners?
How do we build a process/action plan to coordinate these different steps? How do we integrate a CDx into a drug development and launch plan?
How do we support you in your companion diagnostics (CDx) projects
For more than 15 years, Alcimed has been supporting healthcare players, pharmaceutical companies and diagnostic companies, innovative start-ups and healthcare establishments in the area of companion diagnostics.
The diversity of our clients, their challenges and the geographic fields of our projects allows us to have an in-depth understanding of the companion diagnostics market. We have accompanied our clients on numerous issues such as the identification of the key success factors for the development of a CDx, the analysis of regulatory frameworks, the construction of the marketing strategy and business model associated with the launch of a companion diagnostic, the assessment of the market potential of a new CDx technology, the identification of potential partners and possible collaboration models, the implementation of a stakeholder engagement strategy, the optimization of care pathways, the prospective analysis of the CDx market,… and many more!
The types of projects we carry out for our clients in this field are:
EXAMPLES OF RECENT PROJECTS CARRIED OUT FOR OUR CLIENTS IN THE FIELD OF COMPANION DIAGNOSTICS
Based on an in-depth technical and economic study of the various existing diagnostic technologies for pancreatic cancer, we were able to estimate the added value of a new specific biomarker in this environment, specify its advantages and its positioning. Drawing inspiration from other CDx cases, we were able to identify the most suitable business model, and thus assess the potential market for the companion diagnostics considered. Our discussions with players in the sector throughout this project also resulted in operational recommendations for market entry strategy for this new companion test.
After having understood and compared the measures in place between the geographical areas, we have drawn up a table of the regulatory changes expected in the short and medium term for each area. This step was the subject of the creation of a guide of good practices to be put in place to deal with regulatory challenges, intended for our client's local subsidiaries. Finally, we identified the issues around pricing and reimbursement terms to advise our client on the preferred business model to optimize its launch.
Some major strategic partnership plans were drawn up, which we were able to compare and prioritize according to the specific situation and expectations of our client. On the strategic option chosen, we identified the relevant diagnostic players in the context of co-development, and thus informed the choice of our client on the best partner.
Thanks to the analysis of the expected impact of personalized medicine, we were able to provide our client with the knowledge and tools necessary to address the issues of standards and regulations in these two countries.
Our purpose? Helping both private and public decision-makers explore and develop their uncharted territories: new technologies, new offers, new geographies, possible futures, and new ways to innovate.
Located across eight offices around the world (France, Europe, Singapore and the United States), our team is made up of 220 highly-qualified, multicultural and passionate explorers, with a blended science/technology and business culture.
Our dream? To build a team of 1,000 explorers, to design tomorrow's world hand in hand with our clients.
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